Baseline Enrollment Process
1. Screen potential participant using eligibility checklist (same as A0 registration CRF).
2. If eligible, obtain informed consent emphasizing importance of follow up.
3 If study-related procedures are required for confirmation of eligibility criteria (such as blood draw to confirm kidney
sufficiency if not available within 28 days prior to enrollment), conduct after consent and prior to web registration.
4. Obtain participant contact information (PC) and signed authorization for release of records (MR) (If applicable at your
institution).
5. Give questionnaires to participant to complete (approx. 30 minutes total)
 Seattle Angina Questionnaire (SA)
 Patient Health Survey for quality of life (HS)
 Lifestyle Questionnaire (LS)
6. Complete cardiac risk CRF (CR)
 Measure participant’s waist if not recorded in chart
 Determine body mass index (BMI) using table on back of eligibility card which may be obtained from ACRIN
7. Register participant on ACRIN website using the A0 eCRF – a randomization assignment will be returned in 1 min. by e-mail.
8. Determine if ECG has been conducted within the past 30 days; otherwise an ECG must be conducted before or during the
diagnostic imaging examination. If participant is randomized to SPECT, the ECG conducted during this imaging is allowable.
 Collect serum biomarkers only if performed within 28 days of study enrollment. These will be recorded on the EK
form along with the ECG data.
 The creatinine level must be checked within 28 days to determine if the GFR is within protocol specified levels to
establish eligibility criteria; it should be reported on the EK form.
9. Based on randomization assignment, schedule participant to either SPECT or CCTA within 2 weeks after consent.
Optional: Maintain screening log of participants who either failed screening or refused to participate in study.
Data Submission Guidelines
A. Upon Enrollment
1. Submit eCRFs at ACRIN website (www.acrin.org):
 A0 - Registration/Randomization
 CR - Cardiac Risk
 EK – ECG data
 SA – Seattle Angina questionnaire
 HS - Health survey questionnaire
 LS - Lifestyle questionnaire
2. Submit the following to the ACRIN secured efax line at 215-940-8922. This number allows patient names and other PHI
collected on the form to be transmitted to a secure, restricted location.
 Participant Contact Sheet (PC)
 Signed authorization for release of records (MR)
3. Submit the following to the ACRIN Biostatistics Center at Brown University for use with the quality of life sub-study (fax:
401-863-9635). Due to IRB restrictions, ACRIN and Brown cannot share the PC information. You must fax it to each
individual location.
 Copy of the first page of the Participant Contact Sheet (PC)
4. Submit ECG (by US mail or other trackable mode) to:
ECG Submission
ACRIN 4701 Study
American College of Radiology
1818 Market St./Suite 1600
Philadelphia 19103
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B. Randomized Study-Related Imaging
(Participants must be imaged within 2 weeks after consent)
1.
SPECT MPI
a. Submit the following if participant is randomized to SPECT imaging and the performed SPECT is interpretable.
 TS (Technical assessment eCRF)
 SP (SPECT imaging interpretation)
 IW (Image transmittal worksheet)
 NM (SPECT image via TRIAD)
b.
Submit the following if the randomized SPECT is performed but uninterpretable. This alternative is to keep the
participants on trial and avoid withdrawal if possible.
 TS (Technical assessment eCRF)
 SP (SPECT imaging interpretation)
 IW (Image transmittal worksheet)
 NM (SPECT image via TRIAD)
 I2 (Uninterpretable Imaging Form – populated to patient calendar from SP Q2=No)
c.
2.
C.
Submit the following if the randomized SPECT is not performed. Do not complete the SP form. This additional data
is to keep the participants on trial and avoid withdrawal if possible.
 TS (Technical assessment eCRF)
 I3 (Additional Imaging Form – populated to pt. calendar from TS Q2=No)
 PR (Protocol Variation Form – select Q1, option 4)
CCTA
a. Submit the following if participant is randomized to CCTA imaging and the performed CCTA is interpretable.
 TC (Technical assessment eCRF)
 CT (CCTA imaging interpretation)
 IW (Image transmittal worksheet)
 IM (CCTA image via TRIAD)
b.
Submit the following if the randomized CCTA is performed but uninterpretable. This alternative is to keep the
participants on trial and avoid withdrawal if possible.
 TC (Technical assessment eCRF)
 CT (CCTA imaging interpretation)
 IW (Image transmittal worksheet)
 IM (CCTA image via TRIAD)
 I2 (Uninterpretable Imaging Form – populated to patient calendar from CT Q2=No)
c.
Submit the following if the randomized CCTA is not performed. Do not complete the CT form. This additional data
is to keep the participants on trial and avoid withdrawal if possible.
 TC (Technical assessment eCRF)
 I3 (Additional Imaging Form – populated to pt. calendar from TC Q5=No)
 PR (Protocol Variation Form – select Q1, option 4)
If there are positive diagnostic findings on the imaging
1.
Phone Contact 2 weeks after Enrollment
 Submit MACE incident eCRF (MA) form
2.
Phone Contact 2 months after Enrollment
 Submit MACE incident eCRF (MA) form
The participant does not need to be called at 2 weeks and 2 months if there are not positive findings and no MACE event
has been reported.
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